Community oncology practices must have trained, designated teams, standardized protocols, and clearly defined escalation pathways in place before administering a first bispecific dose, according to participants of a recent roundtable discussion hosted by several medical publications. The conversation featured three oncology pharmacy and practice leaders who described what they called the “nonnegotiables” that allowed their programs to launch safely as outpatient operations.
What Makes a Safe Bispecific Launch
Dr. Ralph Boccia, a hematologist-oncologist at the Center for Cancer and Blood Disorders, identified two nonnegotiables that predated his practice’s first commercial bispecific: a restricted T-cell engaging team and a robust set of standard operating procedures. His team had built those capabilities through a prior clinical research program in bispecific and chimeric antigen receptor T-cell therapies, including participation in the steering committee of the EPCORE NHL‑6 trial.
“We would just not allow everyone in the practice to touch these patients,” Boccia said, describing a deliberate decision to limit administration and triage to a named group of physicians and advanced practice providers (APPs). Internal referrals went directly to that team for step-up dosing, with patients transitioning back to their primary oncologist only once stabilized; external referrals were managed by the T‑cell team in full.
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The approach mirrors earlier shifts in oncology when CAR‑T therapy moved from academic to community settings, though bispecifics present a different set of logistical demands because they require repeat dosing and ongoing toxicity monitoring rather than a single infusion.
Boccia noted that entering commercial bispecifics involved a steep learning curve, especially when it came to managing toxicities. Because his practice’s early research trials focused on lymphoma agents rather than myeloma therapies, he had to independently dig into the safety data surrounding cytokine release syndrome. After comparing risk profiles, he chose to implement prophylactic tocilizumab for patients with myeloma at his clinic, while giving other treating physicians across the network the flexibility to make their own clinical calls.
Balancing Specialization and Scale
At Highlands Oncology Group, the decision was to dedicate a single APP to manage all bispecific consults and patient education. “That has been a major change for us, simply because of the education needed,” said Lekan Ajayi, PharmD, the group’s chief operating officer. “This APP will do the consults. Once [the patient is] on a maintenance dose, then the provider team will get the patient back.”
The division of labor has allowed the practice to maintain both quality and throughput without overburdening the broader clinical staff, even as 16 medical oncologists at the site refer patients into the program.
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Zahra Mahmoudjafari, PharmD, director of pharmacy for advanced therapeutics at the University of Kansas Health System, pointed to the practical resource constraints facing most clinics. Most programs rely on shared full-time equivalents across physicians, APPs, pharmacists, infusion nurses, navigators, and financial coordinators — not dedicated bispecific staff.
In that environment, clarity becomes critical. Order set accuracy, toxicity grading protocols, Risk Evaluation and Mitigation Strategy compliance, patient education materials, and triage workflows must be standardized and accessible to everyone on the team, not dependent on a single champion who happens to know how the process works.
Options for Internal Development or External Referral
For practices evaluating whether to develop an internal bispecific program, Boccia suggested talking with peers who have more experience and recognizing that the capability gap is smaller than it may appear. “My hope and prayer is that everyone will be doing bispecifics,” he said. “If you’re not, you’re going to be losing these patients,” because sending them to an academic center for step-up dosing does not guarantee they will come back. “The return…of their patients is very variable depending on the relationship that you have with your academic center.”
Boccia pointed to his network’s publicly available bispecific SOP library, developed through the Emerging Therapies Working Group, as a concrete resource for practices that would otherwise need to start from scratch. A pre‑survey of roundtable participants painted a more complex picture of staffing models that varied widely, with rotating coverage, dedicated cell therapy pharmacists, formal CRS and ICANS order sets, emergency department observation workflows, and pharmacy‑placed as‑needed tocilizumab orders all represented.
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That variation, Mahmoudjafari argued, reflects how highly localized program design must be.
“What works depends on geography, your hospital relationships, your after‑hours access, payer mix, and then that depth of your staffing,” she said.
Panelists consistently emphasized that whatever workflow a practice builds today must also be designed to scale. With bispecific use expected to grow across hematologic malignancies and solid tumors, a process that safely handles two patients per week needs to be stress‑tested for 10, 20, or more. One participant noted that a lack of standardization across the field remains a hindrance, with practices managing as many as 10 different protocols for different bispecifics rather than one unified approach. “[Write] everything in pencil,” Mahmoudjafari advised, noting that practices must continuously adapt their workflows as they gain real‑world experience.
